ENGAGE™ C408508Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734053013), received between Nov 10, 2020 and May 10, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2022Material Separation; Material Separation

  THE SIDE PORT OF THE INTRODUCER DETACHED DURING THE PROCEDURE. THE SHEATH WAS REMOVED AND THE PRESSURE WAS HELD. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14347219 ↗
• MalfunctionApr 28, 2022Material Separation; Material Separation

  APPROXIMATELY FOUR TO SIX WEEKS POST PROCEDURE, THE SIDE PORT DETACHED FROM THE SHEATH. THE PROCEDURE WAS COMPLETED WITH NO ISSUES AND THE PATIENT RETURNED TO THEIR ROOM WITH THE SHEATH STILL IN PLACE. APPROXIMATELY, FOUR TO SIX WEEKS POST PROCEDURE, THE SIDE PORT OF THE SHEATH DETACHED. IT WAS NOTED THAT DURING THE TIME THE SHEATH WAS LEFT IN THE PATIENT, THE IV WOULD OCCASIONALLY BECOME STUCK ON THE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THE SIDE PORT DETACHING AND THE SHEATH WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240770 ↗
• MalfunctionApr 28, 2022Material Separation; Material Separation

  APPROXIMATELY FOUR TO SIX WEEKS POST PROCEDURE, THE SIDE PORT DETACHED FROM THE SHEATH. THE PROCEDURE WAS COMPLETED WITH NO ISSUES AND THE PATIENT RETURNED TO THEIR ROOM WITH THE SHEATH STILL IN PLACE. APPROXIMATELY, FOUR TO SIX WEEKS POST PROCEDURE, THE SIDE PORT OF THE SHEATH DETACHED. IT WAS NOTED THAT DURING THE TIME THE SHEATH WAS LEFT IN THE PATIENT, THE IV WOULD OCCASIONALLY BECOME STUCK ON THE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THE SIDE PORT DETACHING AND THE SHEATH WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240758 ↗
• MalfunctionApr 28, 2022Material Separation; Material Separation

  APPROXIMATELY FOUR TO SIX WEEKS POST PROCEDURE, THE SIDE PORT DETACHED FROM THE SHEATH. THE PROCEDURE WAS COMPLETED WITH NO ISSUES AND THE PATIENT RETURNED TO THEIR ROOM WITH THE SHEATH STILL IN PLACE. APPROXIMATELY, FOUR TO SIX WEEKS POST PROCEDURE, THE SIDE PORT OF THE SHEATH DETACHED. IT WAS NOTED THAT DURING THE TIME THE SHEATH WAS LEFT IN THE PATIENT, THE IV WOULD OCCASIONALLY BECOME STUCK ON THE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THE SIDE PORT DETACHING AND THE SHEATH WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240533 ↗
• MalfunctionAug 19, 2021Material Separation; Material Separation

  DURING THE PROCEDURE, THE SIDEPORT OF THE DEVICE DETACHED. AFTER PLACING A 5F CATHETER THROUGH THE SHEATH, THE SIDEPORT OF THE INTRODUCER DETACHED. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342685 ↗
• MalfunctionNov 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A BLOOD LEAK OCCURRED. WHILE INSERTING THE DEVICE, BLOOD BEGAN TO LEAK FROM THE HEMOSTASIS VALVE. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10820677 ↗